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Removable Partial Dentures Made of PEEK

Clinical Performance of Removable Partial Dentures With Clasps Made of PEEK

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06191107
Acronym
KLAP
Enrollment
50
Registered
2024-01-05
Start date
2024-02-12
Completion date
2028-11-30
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss

Keywords

Removable Partial Denture, Polyetheretherketone, Oral Health Related Quality of Life

Brief summary

As part of the clinical study, 25 patients each were provided with removable partial dentures with clasps made of PEEK in two centres (University Hospital Heidelberg, Department of Prosthodontics and University Hospital for Dental Prosthetics Innsbruck). The patients were examined over a period of 3 years for the number and type of technical or biological complications and questioned about their oral health-related quality of life.

Interventions

Integration of removable partial dentures made of PEEK for the treatment of tooth loss.

Sponsors

Medical University Innsbruck
CollaboratorOTHER
Merz Dental GmbH
CollaboratorUNKNOWN
University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Indication for a clasp-anchored removable partial denture

Exclusion criteria

* Minors and adults unable to give consent * Pregnancy or breastfeeding * Severe general illnesses * Allergies or other intolerances to one of the materials used (PEEK, PMMA) * Suspicion of lack of compliance

Design outcomes

Primary

MeasureTime frameDescription
Oral-Health-Related Quality of Life3 monthsImprovement of Oral-Health-Related Quality of Life (OHRQoL) after incorporation of removable partial dentures made of PEEK (PEEK-RPDs) by using a short version of the validated Oral Health Impact Profile questionnaire with 14 questions (OHIP-G 14). A precise evaluation is obtained by adding up the 14 items with their frequency (never=0, hardly=1, now and then=2, often=3 and very often=4) up to a total value. This value can range from 0 (no limitation of OHRQL) to 56 (severe limitation of OHRQoL). These data are collected before treatment and 3 months after insertion of the PEEK-RPDs.
Biological complications3 yearsBiological complications (intolerances, damage to the abutment teeth and/or the periodontium, survival of abutment teeth) after incorporation of PEEK-RPDs. Measurement tool: Study report form. These data are collected half-yearly after insertion of the PEEK-RPDs.
Technical complications3 yearsTechnical complications (clasp fractures, denture defects) after incorporation of PEEK-RPDs. Measurement tool: Study report form. These data are collected half-yearly after insertion of the PEEK-RPDs.

Countries

Germany

Contacts

Primary ContactThomas Stober, Assoc. Prof.
thomas.stober@med.uni-heidelberg.de004962215636048
Backup ContactBohn Eva-Marie, Assis. Prof.
eva-marie.bohn@med.uni-heidelberg.de004962215638665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026